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A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic Macular Oedema

NCT00148265 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2010-06-23

No results posted yet for this study

Summary

This study is likely to identify an improved and economical treatment for diabetic macular oedema, one of the commonest causes of blindness both in Australia and the rest of the world.The specific aims of the study are to test the following hypotheses:

* That intravitreal triamcinolone followed by laser treatment results in a greater improvement in visual acuity than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes;
* That intravitreal triamcinolone followed by laser treatment results in greater degree of resolution of macular oedema than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes;
* That intravitreal triamcinolone followed by laser treatment results in a reduced requirement for further laser treatment to control diabetic macular oedema than placebo followed by laser treatment;
* That intravitreal triamcinolone followed laser has a manageable and acceptable safety profile in eyes with diabetic macular edema.

Conditions

  • Diabetic Macular Oedema

Interventions

DRUG

Triamcinolone acetate

Eyes assigned to IVTA received an intravitreal injection of 0.1 ml of Kenacort 40© \[40mg/ml triamcinolone acetonide, Bristol-Myers Squibb pharmaceuticals, Australia\] on the day of the baseline visual acuity measurement under sterile conditions in a minor procedures area as an outpatient procedure. Eyes assigned to placebo were prepared in the same way but had the barrel of the syringe without a needle pushed firmly against the eye to simulate an injection.

Sponsors & Collaborators

  • The University of Western Australia

    collaborator OTHER

  • University of Melbourne

    collaborator OTHER

  • Marsden Eye Specialists

    collaborator OTHER

  • University of Sydney

    lead OTHER

Principal Investigators

  • Mark C Gillies, MBBS, PhD · Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney

  • Ian L McAllister, MBBS · Lions Eye Institute, The University of Western Australia

  • Tien Wong, MBBS, PhD · Royal Victoria Eye & Ear Hospital, Department of Ophthalmology, University of Melbourne

  • Jennifer Arnold, MBBS · Marsden Eye Centre Parramatta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00148265 on ClinicalTrials.gov